At a glance
ClinicalIndex Comparison RecordN/ACompleted· 160 enrolled
Drug / intervention
NexGen TM Monoblock Tibia +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
In Brief
A clinical study evaluating NexGen TM Monoblock Tibia and NexGen TM Modular Tibia for Osteoarthritis and 6 related conditions. Completed, enrolled 160 participants across 7 sites.
Detailed Summary
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle, Post-traumatic Loss of Joint Configuration, Moderate Valgus, Varus, or Flexion Deformities
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionMar 2023
Study CompletionMar 2023
TodayJul 2026
First PostedSep 5, 2017
Enrollment StartOct 3, 2017
Primary CompletionMar 30, 2023
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.8 years ago
Interventions
NexGen TM Monoblock Tibiadevice
Primary cementless tibia total knee arthroplasty
NexGen TM Modular Tibiadevice
Primary cementless tibia total knee arthroplasty